A Phase II Study of Axicabtagene Ciloleucel, an Anti-CD19 Chimeric Antigen Receptor (CAR) Tcell Therapy, in Combination With Radiotherapy (RT) in Relapsed/Refractory Follicular Lymphoma
M.D. Anderson Cancer Center
Summary
To learn about the safety of a drug called axicabtagene ciloleucel given in combination with radiation therapy to patients with relapsed/refractory FL.
Description
Primary Objectives: The primary objective of this study is to determine the safety of standard of care axicabtagene ciloleucel with bridging radiotherapy (RT) in patients with relapsed or refractory follicular lymphoma, as assessed by the incidence of grade 3 or higher cytokine release syndrome (CRS) within 30 days after chimeric antigen receptor (CAR) T-cell infusion. Secondary Objectives: * Establish the rates of CRS and ICANS in patients treated with CAR T-cell therapy and radiation * Determine complete response rate (CR) at approximately 1 month post CAR T-cell ---therapy * Determine co…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: Eligible subjects will be considered for inclusion if they meet all of the following criteria: * Men and women 18 years of age or older * Histologically proven FL (Grade 1-3A) on most recent biopsy, history of transformed follicular lymphoma permitted at clinician discretion) * Patients with follicular lymphoma must have disease that has relapsed or is refractory to 2 or more prior lines of systemic therapy * (ECOG) performance status of 0-2 * Medically appropriate for CAR-T cell therapy: adequate organ function CrCL \>/= 45 mL/min/m2, hemoglobin level ≥ 8 g/dl, serum ala…
Interventions
- DrugAxicabtagene Ciloleucel
Given by IV (vein)
- DrugCyclophosphamide
Given by IV (vein)
- DrugFludarabine phosphate
Given by IV (vein)
- DrugPrednisone
Given by IV (vein)
- DrugDiphenhydramine
Given by IV (vein)
- DrugAcetaminophen
Given by IV (vein)
Location
- MD Anderson Cancer CenterHouston, Texas